Watch Now: Getting MDR Clinical Evaluations Right – Practical Guidance for Dental Device Manufacturers

Priya Ray Chaudhuri is an expert in clinical affairs with over a decade of experience in medical writing, clinical evaluation, and post-market surveillance for medical devices. As a manager at Celegence, she oversees global regulatory projects, ensuring alignment with EU MDR, IVDR, MEDDEV 2.7.1 Rev 4, and country-specific requirements. Priya brings deep expertise in authoring and reviewing clinical and performance evaluation reports, PMCF plans, PMS reports, and PSURs across a wide spectrum of therapeutic areas. Beyond documentation, Priya supports strategic decision-making by providing regulatory intelligence, training cross-functional teams, and leading high-value proposal development. Her client-centric mindset, backed by deep technical expertise, ensures consistently successful submissions and long-term regulatory success.

Dr. Manaswitha is a Dentist, with a master's degree in public health. She has 8 years of experience in clinical and public health research. She has authored and reviewed EU MDR compliant regulatory documents (CEP, CER, PMS Report, PMCFER, etc.) for medical devices covering a wide range of therapeutic areas. At Celegence, she is the author and reviewer for clinical evaluation and post-market surveillance documents for medical devices. She also serves as a clinical Subject Matter Expert for dental medical devices.